Safety Study of Combined Radiation and New Drug Treatments for Breast Cancer Including Capecitabine, CDK46 Inhibitors, HER2 Inhibitors, PARP Inhibitors, and Immunotherapy

What this Trial Is About

Radiation therapy is an important part of treating breast cancer, especially as newer drug treatments like HER2 inhibitors, CDK46 inhibitors, PARP inhibitors, capecitabine, and PD1 inhibitors have improved outcomes for specific groups of patients. Many patients need both radiation and ongoing drug therapy, but it is unclear if these treatments should be given at the same time. This research aims to assess the safety of giving radiation alongside these newer systemic therapies for breast cancer patients aged 18 to 70. Participants will receive radiation to the chest wall or breast area, with or without nearby lymph nodes. Alongside radiation, they will be given one of several systemic treatments including capecitabine, HER2 inhibitors such as trastuzumab and pertuzumab, CDK46 inhibitors, PARP inhibitors, or immune checkpoint inhibitors like pembrolizumab. All treatments will be administered concurrently to evaluate combined safety. The study is non-randomized and monitors patients receiving these combined therapies. During the study, participants are closely monitored for side effects, especially severe events graded as 3 or higher. Assessments occur weekly during radiation, then at 4 and 12 weeks after radiation ends, with additional checks if serious symptoms arise within three months post-radiation. Researchers record any adverse events to understand treatment safety. The study is sponsored by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, and will run until January 2027.

Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer